Depressive SymptomsSCOH-ANCT04168684
Intervening Early: Key Adolescent Outcomes
A study testing Attachment and Biobehavioral Catch-up (ABC) and Developmental Education for Families (DEF) in people with Depressive Symptoms and Conduct Disorder, run by University of Delaware at 1 site in United States.
Trial summary
This study follows children into adolescence who were first randomized to intervention condition in infancy. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depressive Symptoms, Conduct Disorder, Anxiety Disorders
- What is being tested?
- Attachment and Biobehavioral Catch-up (ABC) and Developmental Education for Families (DEF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2019to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must have been included in middle childhood data collection
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervening Early With Neglected Children: Key Adolescent Outcomes
This study follows children into adolescence who were first randomized to intervention condition in infancy.
Read the detailed description
Parents serve as co-regulators for their young children, helping them regulate behaviors, emotions, and physiology and supporting the development of healthy brain circuitry. Neglecting parents often fail to serve as co-regulators, which has implications for young children's self-regulatory capabilities and brain development. As children become older, these difficulties with self-regulation may become more pronounced. Adolescence represents a period of particular vulnerability for the emergence of mental health problems because of increasing demands for regulation of emotions and behaviors, coupled with on-going development of neural circuits that support emotional and behavioral regulation. The Attachment and Biobehavioral Catch-up (ABC) intervention was designed to help parents learn to interact in responsive and sensitive ways, with the expectation that children would show enhanced ability to regulate behavior, emotions, and physiology. The efficacy of the ABC intervention among parents involved with Child Protective Services (CPS) was assessed. Parents were randomized to ABC or to a control intervention. Children were followed at T1 (ages 1-4) and T2 (ages 8-10). At T1, more of the children in the ABC group developed secure and organized attachments than children in the DEF group, and children in ABC showed more normative production of cortisol, less expression of negative emotions, and poorer inhibitory control than children in DEF. ABC parents were more sensitive and showed more optimal neural activity than DEF parents. At T2, ABC children showed greater prefrontal cortex activation in response to threat than DEF children, suggesting better regulation to threat at the level of brain activation. Also at T2, children in the ABC group reported more secure relationships with parents, and showed more normative cortisol production and more optimal autonomic nervous system functioning than DEF children. In adolescence, the ABC intervention is expected to result in enhanced brain circuitry and more optimal functioning across domains as assessed at multiple levels of analysis relative to the control intervention. In the proposed study, behavioral and neurobiological development among 13-, 14- and 15-year-old adolescents whose parents were referred by CPS to a randomized controlled trial in infancy (n=120), and among low-risk adolescents followed since middle childhood (n=80) will be assessed.
- Conditions
- Depressive Symptoms, Conduct Disorder, Anxiety Disorders
- Being tested
- Attachment and Biobehavioral Catch-up (ABC), Developmental Education for Families (DEF)
- Medical subject headings
- Depression, Conduct Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Biobehavioral Catch-up (ABC)Behavioural
Manualized intervention implemented in home with parent and child present focused on parental responsiveness
Developmental Education for Families (DEF)Behavioural
Manualized intervention implemented in home with parent and child present focused on parental enhancement of child learning
| Study group | Role | What they receive |
|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) | Experimental | 10 sessions that focused on parental nurturance, and sensitivity Receives: Behavioral: Attachment and Biobehavioral Catch-up (ABC) |
| Developmental Education for Families (DEF) | Active comparator | 10 sessions that focused on cognitive development Receives: Behavioral: Developmental Education for Families (DEF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation in Stop Signal Task
Prefrontal cortex activation assessed through functional magnetic resonance imaging (fMRI) in task requiring inhibitory control
Measured: Child age 13 years
Brain activation in Mother-Stranger Task
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Measured: Age 13 years
Brain activation in Mother-Stranger Task
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Measured: Age 15 years
Brain activation in Emotion Go/Nogo task
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Measured: Age 13 years
Brain activation in Emotional Reappraisal Task
Functional connectivity between amygdala and PFC assessed through fMRI in emotional reappraisal task
Measured: Age 14 years
Brain activation in Emotion Go/Nogo task
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Measured: Age 15 years
Trier Social Stress Test- Cortisol
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997). For the purpose of assessing cortisol, investigators will collect saliva samples before and after the speech/math.
Measured: Age 13 years
Trier Social Stress Test-ANS
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997).Assess child autonomic nervous system regulation, examine reactivity from baseline in RSA.
Measured: Age 13 years
Revealed differences task - parent sensitivity.
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Measured: Age 13 years
Support task- parent sensitivity
Parents and children engage in support discussion (discussing Trier task from previous year). Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Measured: Age 14 years
Revealed differences task- parent sensitivity
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Measured: Age 15 years
Revealed differences task-adolescent competence
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Measured: Age 13 years
Support task-adolescent competence
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Measured: Age 14 years
Revealed differences task-adolescent competence
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Measured: 15 years of age.
Revealed differences task-adolescent ANS
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Parents and children engage in conflict discussion. Assess child autonomic nervous system regulation. Respiratory sinus arrhythmia (RSA) will be measured as a rise from baseline.
Measured: 13 years of age.
Support task-adolescent ANS
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Measured: 14 years of age.
Revealed differences task-adolescent ANS
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Measured: 15 years of age.
Balloon Analogue Risk Task (BART)
This task assesses risk-taking through a computer game in which participants see a balloon on the computer screen and have the option of pumping up the balloon more, and therefore increasing its monetary value, or stopping and collecting the value of the balloon. If the balloon pops on a pump, then all of the value of the balloon is lost and the next trial begins. There is a randomly, pre-determined probability of the balloon popping on any given pump of each trial. A brief version of the task with 15 balloons will be used. A running tally of participants' total monetary gain is kept (and can range from $0 up to a cap of $5). The amount of money earned is the score, with more money reflecting higher risk taking.
Measured: 13 years of age
Delay Discounting
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, \& Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Measured: 13 years of age
Delay Discounting
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, \& Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Measured: 15 years of age
Child Depression
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Measured: 13 years of age
Child Depression
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Measured: 14 years of age
Child Depression
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Measured: 15 years of age
Child problem behaviors
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Measured: 13 years of age
Child problem behaviors
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Measured: 14 years of age
Child problem behaviors
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Measured: 15 years of age
Adolescent substance use
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Measured: 13 years of age
Adolescent substance use
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Measured: 14 years of age
Adolescent substance use
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Measured: 15 years of age
Adolescent risky behaviors
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Measured: 13 years of age
Adolescent risky behaviors
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Measured: 14 years of age
Adolescent risky behaviors
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Measured: 15 years of age
Mini-International Neuropsychiatric Interview for Children and Adolescents
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Measured: 13 years of age
Mini-International Neuropsychiatric Interview for Children and Adolescents
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Measured: 14 years of age
Emotional Regulation Questionnaire
Assesses how effectively adolescents regulate or control emotions. Higher scores reflect better regulation. Scores range from 10-50.
Measured: 14 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start2 Aug 2019
- Primary completion28 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Families randomized to Attachment and Biobehavioral Catch-up (ABC) or to a control intervention (DEF)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Mary Dozier, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168684
- Sponsor's protocol ID
- NIMH074374adol
- Other IDs
- R01MH074374
- Acronym
- SCOH-A
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As described below, data will be made available to the scientific community for further analysis and novel research purposes after the primary results of the study have been published. De-identified research data will be shared in spreadsheet format for all clinical assessment, survey, and behavioral data. MRI data will be shared in NIFTI format. A description of the variables that are included in the dataset as well as a description of the data collection methods will also be provided. All data sharing will be done in consultation with our IRB. Results will be shared within one year of the completion of data collection of primary outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening Early With Neglected Children: Key Adolescent Outcomes
- ClinicalTrials.gov ID
- NCT04168684
- Acronym / sponsor ID
- SCOH-A / NIMH074374adol
- Conditions
- Depressive Symptoms, Conduct Disorder, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study follows children into adolescence who were first randomized to intervention condition in infancy.
Detailed description
Parents serve as co-regulators for their young children, helping them regulate behaviors, emotions, and physiology and supporting the development of healthy brain circuitry. Neglecting parents often fail to serve as co-regulators, which has implications for young children's self-regulatory capabilities and brain development. As children become older, these difficulties with self-regulation may become more pronounced. Adolescence represents a period of particular vulnerability for the emergence of mental health problems because of increasing demands for regulation of emotions and behaviors, coupled with on-going development of neural circuits that support emotional and behavioral regulation. The Attachment and Biobehavioral Catch-up (ABC) intervention was designed to help parents learn to interact in responsive and sensitive ways, with the expectation that children would show enhanced ability to regulate behavior, emotions, and physiology. The efficacy of the ABC intervention among parents involved with Child Protective Services (CPS) was assessed. Parents were randomized to ABC or to a control intervention. Children were followed at T1 (ages 1-4) and T2 (ages 8-10). At T1, more of the children in the ABC group developed secure and organized attachments than children in the DEF group, and children in ABC showed more normative production of cortisol, less expression of negative emotions, and poorer inhibitory control than children in DEF. ABC parents were more sensitive and showed more optimal neural activity than DEF parents. At T2, ABC children showed greater prefrontal cortex activation in response to threat than DEF children, suggesting better regulation to threat at the level of brain activation. Also at T2, children in the ABC group reported more secure relationships with parents, and showed more normative cortisol production and more optimal autonomic nervous system functioning than DEF children. In adolescence, the ABC intervention is expected to result in enhanced brain circuitry and more optimal functioning across domains as assessed at multiple levels of analysis relative to the control intervention. In the proposed study, behavioral and neurobiological development among 13-, 14- and 15-year-old adolescents whose parents were referred by CPS to a randomized controlled trial in infancy (n=120), and among low-risk adolescents followed since middle childhood (n=80) will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Families randomized to Attachment and Biobehavioral Catch-up (ABC) or to a control intervention (DEF)
| Arm | Type | Receives |
|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) | Experimental | Behavioral: Attachment and Biobehavioral Catch-up (ABC)10 sessions that focused on parental nurturance, and sensitivity |
| Developmental Education for Families (DEF) | Active comparator | Behavioral: Developmental Education for Families (DEF)10 sessions that focused on cognitive development |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Must have been included in middle childhood data collection
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC)Manualized intervention implemented in home with parent and child present focused on parental responsiveness | Behavioural | Attachment and Biobehavioral Catch-up (ABC) |
| Developmental Education for Families (DEF)Manualized intervention implemented in home with parent and child present focused on parental enhancement of child learning | Behavioural | Developmental Education for Families (DEF) |
Primary outcome
Brain activation in Stop Signal Task
Time frame: Child age 13 years
Prefrontal cortex activation assessed through functional magnetic resonance imaging (fMRI) in task requiring inhibitory control
Brain activation in Mother-Stranger Task
Time frame: Age 13 years
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Brain activation in Mother-Stranger Task
Time frame: Age 15 years
Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers
Brain activation in Emotion Go/Nogo task
Time frame: Age 13 years
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Brain activation in Emotional Reappraisal Task
Time frame: Age 14 years
Functional connectivity between amygdala and PFC assessed through fMRI in emotional reappraisal task
Brain activation in Emotion Go/Nogo task
Time frame: Age 15 years
Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task
Trier Social Stress Test- Cortisol
Time frame: Age 13 years
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997). For the purpose of assessing cortisol, investigators will collect saliva samples before and after the speech/math.
Trier Social Stress Test-ANS
Time frame: Age 13 years
Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997).Assess child autonomic nervous system regulation, examine reactivity from baseline in RSA.
Revealed differences task - parent sensitivity.
Time frame: Age 13 years
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Support task- parent sensitivity
Time frame: Age 14 years
Parents and children engage in support discussion (discussing Trier task from previous year). Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Revealed differences task- parent sensitivity
Time frame: Age 15 years
Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.
Revealed differences task-adolescent competence
Time frame: Age 13 years
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Support task-adolescent competence
Time frame: Age 14 years
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Revealed differences task-adolescent competence
Time frame: 15 years of age.
Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.
Revealed differences task-adolescent ANS
Time frame: 13 years of age.
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable. Parents and children engage in conflict discussion. Assess child autonomic nervous system regulation. Respiratory sinus arrhythmia (RSA) will be measured as a rise from baseline.
Support task-adolescent ANS
Time frame: 14 years of age.
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Revealed differences task-adolescent ANS
Time frame: 15 years of age.
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.
Balloon Analogue Risk Task (BART)
Time frame: 13 years of age
This task assesses risk-taking through a computer game in which participants see a balloon on the computer screen and have the option of pumping up the balloon more, and therefore increasing its monetary value, or stopping and collecting the value of the balloon. If the balloon pops on a pump, then all of the value of the balloon is lost and the next trial begins. There is a randomly, pre-determined probability of the balloon popping on any given pump of each trial. A brief version of the task with 15 balloons will be used. A running tally of participants' total monetary gain is kept (and can range from $0 up to a cap of $5). The amount of money earned is the score, with more money reflecting higher risk taking.
Delay Discounting
Time frame: 13 years of age
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, \& Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Delay Discounting
Time frame: 15 years of age
Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, \& Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).
Child Depression
Time frame: 13 years of age
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Child Depression
Time frame: 14 years of age
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Child Depression
Time frame: 15 years of age
Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.
Child problem behaviors
Time frame: 13 years of age
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Child problem behaviors
Time frame: 14 years of age
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Child problem behaviors
Time frame: 15 years of age
Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.
Adolescent substance use
Time frame: 13 years of age
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Adolescent substance use
Time frame: 14 years of age
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Adolescent substance use
Time frame: 15 years of age
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.
Adolescent risky behaviors
Time frame: 13 years of age
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Adolescent risky behaviors
Time frame: 14 years of age
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Adolescent risky behaviors
Time frame: 15 years of age
Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.
Mini-International Neuropsychiatric Interview for Children and Adolescents
Time frame: 13 years of age
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Mini-International Neuropsychiatric Interview for Children and Adolescents
Time frame: 14 years of age
Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.
Emotional Regulation Questionnaire
Time frame: 14 years of age
Assesses how effectively adolescents regulate or control emotions. Higher scores reflect better regulation. Scores range from 10-50.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. As described below, data will be made available to the scientific community for further analysis and novel research purposes after the primary results of the study have been published. De-identified research data will be shared in spreadsheet format for all clinical assessment, survey, and behavioral data. MRI data will be shared in NIFTI format. A description of the variables that are included in the dataset as well as a description of the data collection methods will also be provided. All data sharing will be done in consultation with our IRB. Results will be shared within one year of the completion of data collection of primary outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Dozier, Ph.D. principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment and Biobehavioral Catch-up (ABC) and Developmental Education for Families (DEF) in people with Depressive Symptoms and Conduct Disorder, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activation in Stop Signal Task (time frame: Child age 13 years). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.